Kornimate/medical-research-clean huggingface dataset:
pelvic microbiomes of benign and malignant ovarian diseases

Conditions: Microbiota; Ovarian Neoplasms; Ribosome Alteration

Summary: this case-control study aims to compare the pelvic microbiomes of benign ovarian diseases and ovarian malignancies by 16s rna techniques and culture. discharges/flushing fluid from vagina, faces and fimbria end of fallopian tube are collected from age and menopausal status matched patient before and during procedures of laparoscopies. the discharges/flushing fluid would be sent for 16s rna analysis and microculture respectively, and the results would get self-contrasted comparison and case-control comparison.


Eligibility criteria:
inclusion criteria: * laparoscopy procedures * specific pathological diagnosis exclusion criteria: * previous history of pelvic surgeries * evidences of pelvic inflammation diseases
retrospective evaluation of performance of coflex® interlaminer technology versus decompression with or without fusion

Conditions: Spinal Stenosis

Summary: to evaluate clinical, radiologic and patient-reported outcomes who have been treated 1 or 2 levels with the coflex® interlaminar technology or decompression with or without fusion.

the coflex® interlaminar technology - manufactured by paradigm spine - is intended for use as a permanent implant between the lamina of 1 or 2 lumbar motion segments in the treatment of moderate to severe lumbar spinal stenosis. the device is specifically designed to provide stabilization without fusion in cases of stenosis with or without facet joint hypertrophy, subarticular recess stenosis or foraminal stenosis. it is restricted for use to one or two levels in the region of l1 - l5. the height of the neuroforamen is maintained and the facet joints will be relieved. by this a further destruction is prevented. unlike conventional stabilization methods as for example spinal fusion, the function of the segment will be maintained and adjacent structures will be effectively protected. possible risks, which could occur after implantation of the coflex® interlaminar technology are breakage of the implant, displacement of the implant, pain which is caused by the implant, infections, bleedings and hematoma. the benefit of the study lies in the fact that first-time retrospective data is raised for potential improvement regarding therapy of lumbar back pain with the treatment of the lumbar spinal stenosis, which, in the future, can lead to an improvement of the therapy. in this study, paradigm spine will retrospectively collect clinical and radiographic data for patients treated with the coflex® interlaminar technology during normal conditions of use. this data will provide evidence to support publications and marketing.

Eligibility criteria:
inclusion criteria: * patients must meet the criteria specified in the device labeling including radiographic confirmation of at least moderate lumbar stenosis, which narrows the central spinal canal at one or two contiguous levels from l1-l5 that require surgical decompression. exclusion criteria: * there are no exclusion criteria's for this study.
comparison of patient centered outcomes for people with sickle cell disease in the acute care setting

Conditions: Sickle Cell Disease

Summary: the emergency department has been the standard location where patients with sickle cell disease (scd) go to seek care for the treatment of acute painful events. vaso- occlusive crisis (voc) is the most common complication of scd, the purpose of this study is to compare patient centered outcomes for patients being treated for an uncomplicated voc in infusion centers (ic) and emergency departments (ed) in four locations around the united states.

emergency department care is marked by long delays, lack of efficacy, and conflict. a sub-specialty infusion center staffed by expert clinicians and delivering individualized care can improve care quality while reducing costs. the study will examine whether care provided in an infusion center (ic) is more patient centered and efficient than care provided in an emergency department (ed) for adults with sickle cell disease (scd) and uncomplicated vaso-occlusive crisis (voc). sites will prospectively enroll patients in voc seen in participating centers from either the eds or the ics. specific data from the acute visits (e.g. times of arrival, time to first dose of analgesic, etc) will be captured. this study will compare: pain management, disposition of subjects (home or admission) and patient experiences of care delivery in both settings. subjects will complete surveys/questionnaires to asses subjects' experiences in the setting where care was provided. the four sites to participate in the study are baltimore, maryland (johns hopkins hospital), cleveland, ohio (cleveland medical center), milwaukee, wisconsin (medical college of wisconsin), and baton rouge, louisiana (our lady of the lake hospital). a maximum of 500 subjects will participate in the study. participants will be enrolled for 18 months.

Eligibility criteria:
inclusion criteria: * confirmed sickle cell disease patients who live within 60 miles of the study center or who already receive regular care at the participating centers. exclusion criteria: * stable patients who have been on chronic transfusion therapy and have not had a painful episode within two years of enrollment. * patients who are pregnant. * patients who are unwilling or unable to sign consent.
longitudinal investigation of hippocampal function and morphology in acute lymphatic leukemia (all) patients treated with chemotherapy

Conditions: Acute Lymphatic Leukemia

Summary: there are two regions in the adult brain that exhibit neuronal stem and progenitor cells, generating new neurons postnatally and throughout adulthood. one is the so called subventricular zone the other is the dentate gyrus of the hippocampus. adult neurogenesis is a physiological process representing an important functional impact for certain brain areas, especially the hippocampus. the hippocampal formation plays an important role in long-term memory and spatial navigation. inhibition of adult neurogenesis in mice by chemotherapy or radiation is followed by significant deficits in hippocampal memory functions while hippocampus-independent memory is unaffected. clinical trials had shown that chemotherapy and brain radiation lead to cognitive dysfunction. however, the exact mechanisms underlying this phenomenon are still unidentified. the aim of our study is to investigate, whether the inhibition of adult neural stem cell proliferation in the hippocampus by intrathecal chemotherapy and/or cerebral radiation is responsible for treatment induced memory deficits. we will investigate patients suffering from acute lymphatic leukaemia (all) that receive prophylactic intrathecal chemotherapy and brain irradiation. the study represents a longitudinal investigation including a virtual "humanized" version of the morris-water-maze to test hippocampus dependent spatial memory, as well as mr-imaging for morphological (volumetry) and biochemical (spectroscopy) data.


Eligibility criteria:
inclusion criteria: * initial diagnosis of acute lymphatic leukaemia (all) * treatment within the german multicenter adult all (gmall 2003) therapy study * age 18 to 40 years * eligibility for performing study procedure * informed consent exclusion criteria: * neuropsychiatric disorders * present contraindication for mri investigation (e.g. pacemaker)

Keywords: all gmall 2003 chemotherapy hippocampus
intraoperative protective ventilation in abdominal surgery (improve study)

Conditions: Protective Lung Ventilation Using:; Low Tidal Volume (6-8 mL/kg Predicted Body Weight); PEEP of 6-8 cmH2O; Intraoperative RMs

Summary: the purpose of this study is to compare the influence of a lung protective ventilation with conventional ventilation on postoperative complications following major abdominal surgery.

postoperative complications are associated with a significant and quantifiable rate of both morbidity and mortality, increased length of hospital stay and cost of care. intra-abdominal surgery, especially upper abdominal surgery, is an important risk factor of both pulmonary and extra-pulmonary complications. up to 15-20% of patients will develop postoperative respiratory failure which may require respiratory support. recent data from both experimental and clinical studies suggested that, compared with conventional ventilation using high tidal volume (tv) without positive end-expiratory pressure (peep), intraoperative lung protective ventilation using low tidal volume, peep and recruitment maneuvers (rm) could reduce postoperative complications. conventional ventilation promotes sustained cytokine production and could therefore contribute to development of lung injury with in patients with normal lungs. conversely, lung protective ventilation was found to reduce pulmonary and systemic inflammation. the primary objective is to compare a lung protective ventilation with conventional ventilation (high tidal volumes without peep) during abdominal surgery: 1- conventional ventilation with tv of 10-12 ml/kg predicted body weight (pbw) without peep; 2- protective lung ventilation with tv of 6-8 ml/kg pbw, peep of 6-8 cmh2o and rm. our hypothesis is that lung protective ventilation could reduce postoperative pulmonary and extra-pulmonary complications compared with conventional ventilation.

Eligibility criteria:
inclusion criteria: * planned intrabdominal surgery * expected duration ≥ 2 hours * age ≥ 40 yr (and \<90 yr) * risk of postoperative pulmonary complications (arozullah score ≥2) exclusion criteria: * noninvasive ventilation in the last 30 days * recent history of pneumonia, ali/ards (in the last 30 days) * history of pulmonary resection * history of neuromuscular disease * patient refusal

Keywords: mechanical ventilation postoperative pulmonary complications positive end-expiratory pressure protective lung ventilation alveolar recruitment maneuver general anesthesia abdominal surgery
myo-inositol therapy on the dynamics of embryo development in patients suffering from pcos undergoing icsi treatment

Conditions: Polycystic Ovary Syndrome; Infertility

Summary: the purpose of this study is to analyse the activity of myo-inositol on pregnancy rate, embryo development dynamics and oestradiol and progesterone concentration in blood serum and superoxide dismutase (sod) and catalase concentration in follicular fluid of patients with polycystic ovary syndrome (pcos) undergoing intracytoplasmic sperm injection (icsi).


Eligibility criteria:
inclusion criteria: icsi treatment due to infertility pcos patients enrolled according to the criteria established by representatives of the american society of reproductive medicine (asrm) and the european society of human reproduction and embryology (eshre) exclusion criteria: severe endometriosis bmi \ 30 metabolic diseases lowered ovarian reserve

Keywords: polycystic ovary syndrome infertility myo-inositol intracytoplasmic sperm injection
occult paroxysmal atrial fibrillation in patients with non-cardioembolic ischemic stroke of determined mechanism

Conditions: Atrial Fibrillation; Stroke

Summary: the aim of this study is to determine the yield of 3 weeks outpatient mobile cardiac monitoring for detection of atrial fibrillation in patients with history of stroke of known cause.

patients will be recruited to wear a outpatient mobile cardiac monitoring device for detection of atrial fibrillation in patients with a history of stroke of known case. their are not study treatments or interventions, this is an observational trial. eligible patients must be \>50 years old, have a history of ischemic stroke or transient ischemic attack with a documented brain infarction within the prior 12 months. if patients are on anticoagulation therapies, they are eligible for enrollment if the long-term strategy for stroke prevention is anti-platelet therapy and not the oral anti-coagulant itself. patients must not have an detection of af and then must successfully activate the lifestar device for enrollment. at the end of three weeks, the lifestar device will be over-read and scored for the presence of af and other clinically significant arrhythmias by the study electrophysiologist, who will determine the occurrence and burden of af.

Eligibility criteria:
inclusion criteria: 1. age \> 50 2. ischemic stroke, or transient ischemic attack with documented acute brain infarction, within prior 6 months. 3. patient does not merit indefinite oral anticoagulation. (patients requiring temporary oac for purposes other than recurrent stroke prevention, such as treatment of a deep venous thrombosis, are eligible for enrollment if the long-term secondary stroke preventive strategy is anti-platelet therapy and not oac). 4. stroke mechanism is determined to be lacunar stroke, large vessel intracranial atherosclerosis, large vessel extracranial atherosclerosis, or a combination thereof. 5. patient has been evaluated with at least a 12 lead ekg and at least one day of in-patient or out-patient cardiac telemetry, with no detection of af or atrial flutter. 6. detection of af or atrial flutter would change secondary prevention antithrombotic strategy (eg to indefinite oac). 7. patient receives and successfully activates lifestar act device. 8. patient or legally authorized representative signs informed consent. exclusion criteria: 1. known history of af or atrial flutter. 2. patient has defibrillator or pacemaker capable of detecting af. 3. patient has indication for indefinite oac. 4. patient has indefinite contra-indication to oac. (patients with temporary ineligibility for oac, for example due to the need for invasive medical procedures or large acute brain infarction, are eligible for enrollment). 5. stroke due to known cause not listed in inclusion criterion 4. 6. cardioembolic stroke. 7. inability to comply with lifestar act monitoring regimen.

Keywords: atrial fibrillation stroke
trial of myocet in metastatic breast cancer

Conditions: Breast Cancer

Summary: the purpose of the study is to examine the safety and effectiveness of the drug combination of myocet, paclitaxel and trastuzumab compared to paclitaxel and trastuzumab without myocet, as first line treatment for patients with metastatic her2+ breast cancer.


Eligibility criteria:
inclusion criteria: * metastatic her2+ breast cancer by fish analysis * no prior chemotherapy for metastatic disease * measurable disease * normal left ventricular ejection fraction exclusion criteria: * prior doxorubicin treatment exceeding 300 mg/m2 or epirubicin exceeding 600 mg/m2 * relapse within 12 months of completion of adjuvant trastuzumab, taxane or anthracycline therapy

Keywords: metastatic her2+ breast cancer myocet liposomal doxorubicin trastuzumab
expanded access for cc-4047

Conditions: Multiple Myeloma

Summary: this is an expanded access program (eap) for eligible participants designed to provide access to cc-4047.


Eligibility criteria:
inclusion criteria: - exclusion criteria: -

Keywords: expanded access compassionate use
causes of low back pain in nurses in israeli hospitals

Conditions: Low Back Pain

Summary: an examination of the various factors that cause lower back pain in nurses in four hospitals in israel such as; socio-demographic, professional, posture while ambulating patients and job environment.


Eligibility criteria:
inclusion criteria: * nurses working in orthopedics, surgical, intensive care and internal medicine units exclusion criteria: * all others

Keywords: low back pain in nurses
epidural steroid injections in post-lumbar surgery syndrome after single-level discectomy

Conditions: Failed Back Surgery Syndrome; Low Back Pain; Radiculopathy; Epidural Fibrosis

Summary: 62 patients with postlumbar surgery syndrome were randomized and divided into two groups. transforaminal epidural steroid injection (tfesi) was applied to the tfesi group (n=31), and caudal epidural steroid injection (cesi) was applied to the cesi group (n=31). the age of the patients involved in this study ranged from 18 years old to 65 years old

patients with low back and radicular pain related to epidural fibrosis following single-level lumbar discectomy were included. the patients were randomly divided into two groups as the cesi group and tfesi group. transforaminal epidural steroid injection was applied to the tfesi group (n=31), and caudal epidural steroid injection was applied to the cesi group (n=31). all patients were assessed before the procedure (baseline) and at 1 hour, three weeks, and three months after the procedure using the numerical rating scale (nrs) and at baseline and three weeks and three months using the modified oswestry disability index (modi). treatment success was defined as ≥50% decrease in the nrs scores compared to baseline

Eligibility criteria:
inclusion criteria: * age between 18 and 65 years * previous single-level, open, non-fusion discectomy for l4-5 or l5-s1 lumbar disc herniation within the past six months * having epidural fibrosis involving the l4, l5 or s1 nerve root on magnetic resonance imaging * having low back and leg pain for at least six months and unresponsive to conservative therapies * a numerical rating scale score of ≥4 * having a single-level epidural fibrosis in the operated level and side as assessed by contrast-enhanced spinal magnetic resonance imaging exclusion criteria: * having a multi-level epidural fibrosis * previous surgery for multi-level disc herniation * previous lumbar fusion surgery * having recurrent disc hernia * having sacroiliac/facet joint pain * having lumbar spinal stenosis, spondylolysis, spondylolisthesis, or scoliosis * history of epidural steroid injection within the past six months * having bleeding diathesis * presence of systemic or local infections * pregnancy * known hypersensitivity to the injectates to be applied

Keywords: failed back surgery syndrome, epidural steroid injections
a study of aav9 gene therapy in participants with canavan disease (canaspire clinical trial)

Conditions: Canavan Disease

Summary: the main objective of this trial is to evaluate the safety, tolerability, and pharmacodynamic activity of bbp-812, an investigational aav9-based gene therapy, in pediatric participants with canavan disease.

canavan disease is an ultra-rare, profoundly disabling and fatal disease with no approved therapy. the sponsor is developing bbp-812, an investigational gene therapy product for systemic delivery in participants with canavan disease. bbp-812 is a recombinant adeno-associated virus serotype 9 (raav9) vector engineered to deliver the aspartoacylase (aspa) transgene under control of a ubiquitous promoter to restore aspa expression in both neuronal and non-neuronal cell types.

Eligibility criteria:
key inclusion criteria: * maximum age for inclusion is 30 months. * participant has stable health in the opinion of the investigator and as confirmed by medical history and laboratory studies with no acute or chronic hematologic, renal, liver, immunologic, or neurologic disease (other than canavan disease). * participant has biochemical, genetic, and clinical diagnosis of canavan disease: * elevated urinary naa and * biallelic mutation of the aspa gene determined at screening or documented in the participant's medical history. * active clinical signs of canavan disease * participant is up to date on all immunizations per local guidelines key exclusion criteria: * tests positive for total anti-aav9 antibodies determined by enzyme-linked immunosorbent assay (elisa). * received prior gene therapy or other therapy (including vaccines) involving aav. * participant is receiving high-dose therapy with immunosuppressants. * participant has significantly progressed canavan disease characterized as: * presence of continuous/constant decerebrate or decorticate posturing, * recurrent status epilepticus, or * recalcitrant seizures that do not respond while on 3 or more anti-epileptic medications

Keywords: canavan disease aav aav9 gene therapy aspartoacylase aspa aspa gene raav9 acy2 aminoacylase 2 spongy degeneration n-acetyl-l-aspartic acid (naa) n-acetylaspartate rare disease inherited metabolic disorders leukodystrophy leukoencephalopathies autosomal recessive disorder neurodevelopmental diseases canaspire clinical trial
an interactive game for hiv prevention in early adolescents

Conditions: HIV; Risk Reduction

Summary: the purpose of this study is to evaluate, through a randomized clinical trial, the efficacy of an interactive video game the investigators are developing at reducing risk behaviors in at-risk teens.

the purpose of this study is to evaluate, through a randomized clinical trial, the efficacy of an interactive video game the investigators are developing at reducing risk behaviors in at-risk teens. the investigators are using proven components of hiv prevention interventions, social cognitive theory, self-efficacy, prospect theory, message framing, and video gaming principles to develop and evaluate this interactive hiv prevention video game. in phase 1 of this project, the investigators have been working with schell games of pittsburgh, pa, digitalmill of portland, me, and the farnam neighborhood house in new haven, ct to develop our interactive video game with the input from our experts and focus groups and interviews with adolescents. phase 1 has been a developmental iterative process in which the investigators have been building the software for the game for the purposes of targeting hiv prevention in our population of interest: young minority adolescents. following development of the video game, the investigators will move to phase 2 in which the investigators will enroll 330 minority adolescents who are attendees at one of several after-school programs in the greater new haven area and assign them to play either the experimental game or a control game. in the experimental game, the player will be presented with a series of "risk challenges" thereby helping them to develop sex, drug and alcohol negotiation and refusal skills.

Eligibility criteria:
inclusion criteria: 1. ages 11-14 years 2. able to provide assent/parental/guardian consent 3. agree to participate in a computer-based videogame (willing to sit at a computer for 75 minutes twice weekly to play the game) 4. english-speaking exclusion criteria: 1. not between the ages of 11-14 years 2. not able to provide assent/parental/guardian consent 3. not willing to sit at a computer for 75 minutes twice weekly to play the game 4. non-english speaking

Keywords: adolescent risk hiv video games